The Recall Desk
HighFDA (Devices)·Z-2894-2016·Announced 2016-10-05

Zyno Medical Administration Set Recalled for Potential Filter Leaking

Zyno Medical LLC is recalling 78,069 sterile administration sets because the filter may leak. The sets are used to administer fluids to patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device used for vascular fluid administration where a leak could pose a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zyno Medical LLC is recalling 78,069 units of the Zyno Medical Administration Set, Sterile (Product Code: A2-80072-F). The recall was initiated because the device's filter may leak. These sets are prescription devices used to administer fluids from a container to a patient's vascular system through a needle or catheter, and are intended for use with Zyno Medical Infusion Pumps or gravity feed.

The affected units were distributed nationwide in the United States. The recall covers specific lot codes, including 14015257, 14016574, and 14026116, among others listed in the agency's documentation. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and consumers should stop using the affected administration sets immediately. Users should check the lot codes on their inventory against the list provided by the FDA or Zyno Medical LLC. For more information, contact Zyno Medical LLC or refer to the FDA recall notice Z-2894-2016.

The recalled product

Product
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion/IV Sets
Hazard
Affected units
78,069

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Zyno Medical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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